Wright Simonne L, Kessler Anna, Sijbrandij Marit, Karyotaki Eirini, Cuijpers Pim, Bisson Jonathan, Brady Kathleen, Dowd Sheila M, Dunlop Boadie W, Pollack Mark H, Rothbaum Barbara O, Seedat Soraya
Department of Clinical, Neuro- and Developmental Psychology, World Health Organization Collaborating Center for Research and Dissemination of Psychological Interventions, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
South Africa PTSD Research Programme of Excellence, Department of Psychiatry, Faculty of Medicine & Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
Eur J Psychotraumatol. 2025 Dec;16(1):2504839. doi: 10.1080/20008066.2025.2504839. Epub 2025 May 28.
Dropout rates and factors contributing to dropout in drug and placebo groups in pharmacotherapy trials for posttraumatic stress disorder (PTSD) are not well understood. This study aimed to examine differences in all-cause study dropouts between drug and placebo groups, using conventional meta-analysis and an exploratory predictor analysis of individual participant data from three trials. We included randomized controlled trials (RCTs) of adults with PTSD, comparing drug monotherapy with placebo. Forty-three RCTs ( = 4829) were included in a conventional meta-analysis. Additionally, we conducted a small exploratory predictor analysis including participant-level data from three RCTs ( = 246). In the conventional meta-analysis, study dropout was marginally lower in the drug relative to the placebo group, but the difference was not significant, RR = 0.92, 95% CI [0.83, 1.02], = .099. Drug class, dosing regimen, population, study duration, or gender were not related to dropout.In the exploratory predictor analysis, study dropout did not differ significantly between drug and placebo groups = .617). In the drug group, gender was a significant predictor for dropout, with males having higher dropout rates ( = .046). When controlling for baseline PTSD symptom severity, gender was no longer a statistically significant predictor ( = .051). None of the other predictors in group analyses were significant in predicting drop-out. This study demonstrated that study dropout rates in monotherapy pharmacotherapy RCTs for PTSD do not significantly differ between drug and placebo groups. These findings underscore the need for further research to identify the factors contributing to dropout in PTSD pharmacotherapy trials and to develop tailored treatment adherence strategies. Additionally, they highlight the importance of pooling participant-level data to facilitate more comprehensive and granular analyses in future research.
在创伤后应激障碍（PTSD）药物治疗试验中，药物组和安慰剂组的脱落率以及导致脱落的因素尚未得到充分了解。本研究旨在通过传统的荟萃分析以及对来自三项试验的个体参与者数据进行探索性预测分析，来检验药物组和安慰剂组之间全因研究脱落的差异。我们纳入了患有PTSD的成年人的随机对照试验（RCT），比较药物单一疗法与安慰剂。43项RCT（n = 4829）被纳入传统的荟萃分析。此外，我们进行了一项小型探索性预测分析，包括来自三项RCT（n = 246）的参与者层面数据。在传统的荟萃分析中，相对于安慰剂组，药物组的研究脱落率略低，但差异不显著，RR = 0.92，95%CI[0.83，1.02]，P = 0.099。药物类别、给药方案、人群、研究持续时间或性别与脱落无关。在探索性预测分析中，药物组和安慰剂组之间的研究脱落率没有显著差异（P = 0.617）。在药物组中，性别是脱落的一个显著预测因素，男性的脱落率更高（P = 0.046）。在控制基线PTSD症状严重程度后，性别不再是一个具有统计学意义的预测因素（P = 0.051）。分组分析中的其他预测因素均未在预测脱落方面具有显著性。本研究表明，PTSD单一疗法药物治疗RCT中的研究脱落率在药物组和安慰剂组之间没有显著差异。这些发现强调了需要进一步研究以确定PTSD药物治疗试验中导致脱落的因素，并制定针对性的治疗依从性策略。此外，它们突出了汇总参与者层面数据以促进未来研究中更全面和细致分析的重要性。
